Open-cavity, reduced-pressure treatment devices and systems

ABSTRACT

An open-cavity, reduced-pressure treatment device and system for treating a cavity in a patient&#39;s body, such as an abdominal cavity, is presented. In one instance, an open-cavity, reduced-pressure treatment device includes a plurality of encapsulated leg members, each having an interior portion with a leg manifold member and formed with fenestrations operable to allow fluid flow into the interior portion, and a central connection member fluidly coupled to the plurality of encapsulated leg members. The central connection member has a connection manifold member. The open-cavity, reduced-pressure treatment devices, systems, and methods allow for, among other things, removal of fluids.

RELATED APPLICATIONS

The present application is a divisional of U.S. patent application Ser.No. 12/467,064, filed May 15, 2009 entitled “Open-Cavity,Reduced-Pressure Treatment Devices and Systems”, which claims thebenefit, under 35 USC § 119(e), of the filing of U.S. Provisional PatentApplication Ser. No. 61/109,410, entitled “Reduced-Pressure,Wound-Closure System and Method,” filed Oct. 29, 2008; U.S. ProvisionalPatent Ser. No. 61/109,486, entitled “Reduced-Pressure, AbdominalTreatment System and Method,” filed Oct. 29, 2008; U.S. ProvisionalPatent Application Ser. No. 61/109,390, entitled “Open-Cavity,Reduced-Pressure Wound Dressing and System,” filed Oct. 29, 2008; andU.S. Provisional Patent Application Ser. No. 61/109,448, entitled“Reduced-Pressure, Deep-Tissue Closure System and Method,” filed Oct.29, 2008. All of these provisional applications are incorporated hereinby reference for all purposes.

BACKGROUND

The present invention relates generally to medical treatment systemsand, more particularly, to open-cavity, reduced-pressure treatmentdevices and systems.

Whether the etiology of a wound, or damaged area of tissue, is trauma,surgery, or another cause, proper care of the wound, or wounds, isimportant to the outcome. Unique challenges exist when the woundinvolves locations that require reentry, for example, the peritonealcavity and more generally the abdominal cavity. Often times when surgeryor trauma involves the abdominal cavity, establishing a wound managementsystem that facilitates reentry, allows for better and easier care, andhelps to address such things as peritonitis, abdominal compartmentsyndrome, and infections that might inhibit final healing of the woundand the internal organs. In providing such care, it may be desirable toremove unwanted fluids from the cavity, help approximate the fascia andother tissues, and finally to help provide a closing force on the wounditself at the level of the epidermis.

Currently, an abdominal opening on the epidermis may be closed usingsutures, staples, clips, and other mechanical devices to allow the skin,or epidermis, to be held and pulled. Such devices cause wounds in and ofthemselves. Moreover, without more, if edema occurs, tremendous pressuremay be placed on the closure device with potential harm resulting. Forexample, if pressure rises due to edema, sutures may tear out.

With respect to an overall system for allowing reentry into theabdominal cavity, a number of techniques have been developed. Oneapproach is to place towels down into the cavity and then use clips,such as hemostats, to close the skin over the towels. While simple andfast, the results appear to have been regarded as suboptimal. Anotherapproach is the “Bogota bag.” With this approach, a bag is sutured intoplace to cover the open abdomen. Still another approach, sometimescalled a “vac pack,” has been to pack towels in the wound and then placea drain into the abdomen and cover the abdomen with a drape. Finally, areduced pressure approach has been used. Such an approach is shown inU.S. Pat. No. 7,381,859 to Hunt et al. and assigned to KCI Licensing,Inc. of San Antonio, Tex. U.S. Pat. No. 7,381,859 is incorporated hereinby reference for all purposes.

In addition to accessing the cavity for reentry, it may be desirable toremove fluids from the cavity. It may also be desirable to providereduced-pressure therapy to the tissue or wound, including wounds thatmay be within the abdominal cavity. This treatment (frequently referredto in the medical community as “negative pressure wound therapy,”“reduced pressure therapy,” or “vacuum therapy”) may provide a number ofbenefits, including faster healing and increased formulation ofgranulation tissue.

It would be desirable to provide a system and method that could removeexcess fluids from an abdominal cavity, protect the interior of theabdominal cavity by providing a non-adherent barrier, and deliverreduced pressure. Further, it would be desirable to provide a systemthat can be readily placed in various locations in the abdominal cavity,such as paracolic gutters, is quickly installed, and that easilyaccommodates different size areas.

SUMMARY

Shortcomings with existing dressings and systems for open cavities, suchas abdominal cavities, are addressed by the systems, apparatus, andmethods of the illustrative embodiments described herein. According toone illustrative embodiment, a reduced-pressure treatment system forproviding reduced-pressure treatment within a body cavity of a patientmay include a treatment device having a plurality of encapsulated legmembers, each encapsulated leg member having an interior portion with aleg manifold member and formed with fenestrations operable to allowfluid flow into the interior portion. The treatment device also includesa central connection member having a connection manifold member andwherein each leg manifold member is in fluid communication with theconnection manifold member. The central connection member has a firstside and a second, inward-facing side. The reduced-pressure treatmentsystem further includes a manifold for disposing proximate the firstside of the central connection member and operable to distribute reducedpressure to the central connection member; a sealing member fordisposing on a portion of the patient's epidermis and operable to form apneumatic seal over the body cavity; a reduced-pressure conduit; and areduced-pressure source for producing reduced pressure. Thereduced-pressure source is fluidly coupled to the reduced-pressuredelivery conduit, which is fluidly coupled to a reduced-pressureinterface.

According to another illustrative embodiment, an open-cavity,reduced-pressure treatment device for treating a tissue site in a bodycavity includes a plurality of encapsulated leg members, eachencapsulated leg member having an interior portion with a leg manifoldmember. The plurality of encapsulated leg members are formed withfenestrations operable to allow fluid flow into the interior portion.The open-cavity, reduced-pressure treatment device also includes acentral connection member, which has a connection manifold member. Theplurality of encapsulated leg members are in fluid communication withthe connection manifold member.

According to another illustrative embodiment, a method of manufacturinga reduced-pressure treatment device for use in a body cavity of apatient includes the steps of: forming a plurality of encapsulated legmembers, each encapsulated leg member having an interior portion with aleg manifold member and formed with fenestrations operable to allowfluid flow into the interior portion. The method of manufacturing areduced-pressure treatment device further includes forming a centralconnection member having a connection manifold member and fluidlycoupling the central connection member to the plurality of encapsulatedlegs, wherein each leg manifold member is in fluid communication withthe connection manifold member. The illustrative method may also includeplacing visual indicia on the non-adherent drape that indicates varioussizes that might be cut.

According to another illustrative embodiment, a method of providingreduced-pressure treatment in an abdominal cavity of a patient mayinclude the steps of: disposing a treatment device into the abdominalcavity, wherein the treatment device has a plurality of encapsulated legmembers, each encapsulated leg member having an interior portion with aleg manifold member and formed with fenestrations operable to allowfluid flow into the interior portion, and a central connection member,wherein the central connection member has a connection manifold memberand wherein each leg manifold member is in fluid communication with theconnection manifold member. The central connection member has a firstside and a second, inward-facing side. The method further includesplacing at least one of the plurality of encapsulated leg membersproximate a paracolic gutter in the abdominal cavity; disposing amanifold proximate the first side of the central connection member;placing a sealing member on a portion of the patient's epidermis to forma pneumatic seal over the body cavity; coupling a reduced-pressureinterface to the sealing member; and coupling a reduced-pressure conduitto the reduced-pressure interface to deliver reduced pressure to themanifold. The illustrative method may further include the step of sizingthe treatment device before disposing the treatment device into the bodycavity.

Other objects, features, and advantages of the illustrative embodimentswill become apparent with reference to the drawings and detaileddescription that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a schematic diagram, with a portion in cross section, of anillustrative embodiment of an open-cavity, reduced-pressure treatmentdevice and system;

FIG. 1B is a schematic cross section of a portion of the treatmentdevice of FIG. 1A;

FIG. 1C is a schematic cross section of a portion of the treatmentdevice of FIG. 1A taken along line 1C-1C;

FIG. 1D is a schematic cross section of a portion of the system of FIG.1A;

FIG. 2 is a schematic, perspective view of the illustrative embodimentof an open-cavity, reduced-pressure treatment device of FIGS. 1A-1D;

FIG. 3A is a schematic, plan view of another illustrative embodiment ofan open-cavity, reduced-pressure treatment device;

FIG. 3B is a schematic, plan view of a portion of the treatment deviceof FIG. 3A;

FIG. 3C is a schematic cross section of a portion of the treatmentdevice of FIG. 3B taken along line 3C-3C;

FIG. 4 is schematic, perspective view of another illustrative embodimentof an open-cavity, reduced-pressure treatment device; and

FIG. 5 is a schematic, plan view of another illustrative embodiment ofan open-cavity, reduced-pressure treatment device.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of the illustrative embodiments,reference is made to the accompanying drawings that form a part hereof.These embodiments are described in sufficient detail to enable thoseskilled in the art to practice the invention, and it is understood thatother embodiments may be utilized and that logical structural,mechanical, electrical, and chemical changes may be made withoutdeparting from the spirit or scope of the invention. To avoid detail notnecessary to enable those skilled in the art to practice the embodimentsdescribed herein, the description may omit certain information known tothose skilled in the art. The following detailed description is,therefore, not to be taken in a limiting sense, and the scope of theillustrative embodiments are defined only by the appended claims.

Referring to FIGS. 1A-1D, an illustrative embodiment of an open-cavity,reduced-pressure system 100 and a treatment device 102 is presented. Theopen-cavity reduced-pressure system 100 and the treatment device 102 arefor treating a tissue site 104 of a patient. The tissue site 104 may bethe bodily tissue of any human, animal, or other organism, includingbone tissue, adipose tissue, muscle tissue, dermal tissue, tissue,connective tissue, cartilage, tendons, ligaments, or any other tissue.In this illustrative embodiment, the tissue site 104 includes tissue ina body cavity, and in particular the abdominal cavity, and includes theabdominal contents or tissue that is proximate the abdominal cavity.Treatment of the tissue site 104 may include removal of fluids, e.g.,ascites, protection of the abdominal cavity, or reduced-pressuretherapy. Unless otherwise indicated, as used herein, “or” does notrequire mutual exclusivity.

As shown, the treatment device 102 is disposed within the abdominalcavity of the patient to treat the tissue site 104. The treatment device102 includes a plurality of encapsulated leg members 106 that aresupported by the abdominal contents, which make up a surface on whichthe plurality of leg members 106 are placed. One or more of theplurality of encapsulated leg members 106 may be placed in or proximateto a first paracolic gutter 108, and one or more of the plurality ofencapsulated leg members 106 may be placed in or proximate to a secondparacolic gutter 110. The plurality of encapsulated leg members 106 iscoupled to a central connection member 112, and there is fluidcommunication between the plurality of encapsulated leg members 106 andthe central connection member 112. The plurality of encapsulated legmembers 106 and/or the central connection member 112 may be formed withfenestrations 114, 116, 118, 120 that allow fluids in the abdominalcavity to pass through. The fenestrations 114, 116, 118, 120 may takeany shape, e.g., circular apertures, rectangular openings, polygons,etc., but are presented in this illustrative embodiment as slits, orlinear cuts. One or more fenestrations 114, 116, 118, 120 might beomitted in alternative embodiments.

A manifold 122, or manifold pad, distributes reduced pressure to thetreatment device 102. A sealing member 124 provides a pneumatic sealover body-cavity opening 126. One or more skin closure devices may beplaced on a patient's epidermis 134. Reduced pressure is delivered tothe manifold 122 through a reduced-pressure interface 128, which iscoupled to a reduced-pressure delivery conduit 130. A reduced-pressuresource 132 delivers reduced pressure to the reduced-pressure deliveryconduit 130.

The reduced pressure may be applied to the tissue site 104 to helppromote removal of ascites, exudates, or other fluids from the tissuesite 104. In some instances, reduced pressure may be applied tostimulate the growth of additional tissue. In some instances, only fluidremoval may be desired. In the case of a wound at the tissue site 104,the growth of granulation tissue, removal of exudates, or removal ofbacteria may help to promote healing of the wound. In the situation of anon-wounded or non-defective tissue, reduced pressure may be used insome instances to promote the growth of tissue that may be harvested andtransplanted to another tissue site. As used herein, “reduced pressure”generally refers to a pressure less than the ambient pressure at atissue site that is being subjected to treatment. In most cases, thisreduced pressure will be less than the atmospheric pressure at which thepatient is located. Alternatively, the reduced pressure may be less thana hydrostatic pressure at the tissue site. Reduced pressure mayinitially generate fluid flow in the manifold 122, the reduced-pressureconduit 130, and proximate the tissue site 104. As the hydrostaticpressure around the tissue site 104 approaches the desired reducedpressure, the flow may subside, and the reduced pressure may bemaintained. Unless otherwise indicated, values of pressure stated hereinare gauge pressures.

The manifold 122 is proximate the central connection member 112. Themanifold 122 may take many forms. The term “manifold” as used hereingenerally refers to a substance or structure that is provided to assistin applying reduced pressure to, delivering fluids to, or removingfluids from the tissue site 104. The manifold 122 typically includes aplurality of flow channels or pathways that distribute the fluidsprovided to and removed from the tissue site 104 around the manifold 122and through the central connection member 112. In one illustrativeembodiment, the flow channels or pathways are interconnected to improvedistribution of fluids provided or removed from the tissue site 104. Themanifold 122 may be a biocompatible material that is capable of beingplaced in contact with the tissue site 104 and distributing reducedpressure to the tissue site 104. Examples of manifold 122 may include,without limitation, devices that have structural elements arranged toform flow channels, cellular foam, such as open-cell foam, porous tissuecollections, liquids, gels and foams that include or cure to includeflow channels. The manifold 122 may be porous and may be made from foam,gauze, felted mat, or any other material suited to a particularbiological application. In one embodiment, the manifold 122 is a porousfoam and includes a plurality of interconnected cells or pores that actas flow channels. The porous foam may be a polyurethane, open-cell,reticulated foam, such as a GranuFoam® material manufactured by KineticConcepts, Incorporated of San Antonio, Tex. Other embodiments mightinclude “closed cells.” These closed-cell portions of the manifold maycontain a plurality of cells, the majority of which are not fluidlyconnected to adjacent cells. The closed cells may be selectivelydisposed in the manifold 122 to prevent transmission of fluids throughperimeter surfaces of the manifold 122. In some situations, the manifold122 may also be used to distribute fluids such as medications,antibacterials, growth factors, and various solutions to the tissue site104. Other layers may be included in or on the manifold 122, such asabsorptive materials, wicking materials, hydrophobic materials, andhydrophilic materials.

The sealing member 124 is placed over the body-cavity opening 126 andprovides a pneumatic seal adequate for the open-cavity, reduced-pressuresystem 100 to hold a reduced pressure at the tissue site 104. Thesealing member 124 may be a cover that is used to secure the manifold122 on the central connection member 112. The sealing member 124 may beimpermeable or semi-permeable. The sealing member 124 is capable ofmaintaining reduced pressure at the tissue site 104 after installationof the sealing member 124 over the body-cavity opening 126. The sealingmember 124 may be a flexible over-drape or film formed from asilicone-based compound, acrylic, hydrogel or hydrogel-forming material,or any other biocompatible material that includes the impermeability orpermeability characteristics as desired for applying reduced pressure tothe tissue site 104.

The sealing member 124 may further include an attachment means 131 tosecure the sealing member 124 to the patient's epidermis 134. Theattachment means 131 may take many forms; for example, an adhesive layer136 may be positioned along a perimeter of the sealing member 124 or anyportion of the sealing member 124 to provide, directly or indirectly,the pneumatic seal with the patient's epidermis 134. The adhesive layer136 might also be pre-applied to the sealing member 124 and covered witha releasable backing, or member (not shown), that is removed at the timeof application.

The reduced-pressure interface 128 may be, as one example, a port orconnector 138, which permits the passage of fluid from the manifold 122to the reduced-pressure delivery conduit 130 and vice versa. Forexample, fluid collected from the tissue site 104 using the manifold 122and the treatment device 102 may enter the reduced-pressure deliveryconduit 130 via the connector 138. In another embodiment, theopen-cavity, reduced-pressure system 100 may omit the connector 138 andthe reduced-pressure delivery conduit 130 may be inserted directly intothe sealing member 124 and into the manifold 122. The reduced-pressuredelivery conduit 130 may be a medical conduit or tubing or any othermeans for transportating a reduced pressure and fluid. Thereduced-pressure delivery conduit 130 may be a multi-lumen member forreadily delivering reduced pressure and removing fluids. In oneembodiment, the reduced-pressure delivery conduit 130 is a two-lumenconduit with one lumen for reduced pressure and liquid transport and onelumen for communicating pressure to a pressure sensor.

Reduced pressure is generated and supplied to the reduced-pressuredelivery conduit 130 by the reduced-pressure source 132. A wide range ofreduced pressures may be generated or supplied by the reduced-pressuresource 132. In one embodiment, the range may include the range −50 to−300 mm Hg and in another embodiment, the range may include −100 mm Hgto −200 mm Hg. In one illustrative embodiment, the reduced-pressuresource 132 includes preset selectors for −100 mm Hg, −125 mm Hg, and−150 mm Hg. The reduced-pressure source 132 may also include a number ofalarms, such as a blockage alarm, a leakage alarm, or a battery-lowalarm. The reduced-pressure source 132 could be a portable source, wallsource, or other unit for abdominal cavities. The reduced-pressuresource 132 may selectively deliver a constant pressure, varied pressure,intermittent pressure, or continuous pressure. The fluid removed fromthe cavity through the reduced-pressure delivery conduit 130 could be asmuch as 5 L or more per day.

A number of different devices, e.g., device 140, may be added to amedial portion 142 of the reduced-pressure delivery conduit 130. Forexample, the device 140 might be a fluid reservoir, or canistercollection member, a pressure-feedback device, a volume detectionsystem, a blood detection system, an infection detection system, afilter, a port with a filter, a flow monitoring system, a temperaturemonitoring system, etc. Multiple devices 140 might be included. Some ofthese devices, e.g., the fluid collection member, may be formed integralto the reduced-pressure source 132. For example, a reduced-pressure port144 on the reduced-pressure source 132 may include a filter member (notshown) that includes one or more filters and may include a hydrophobicfilter that prevents liquid from entering an interior space of thereduced-pressure source 132.

Referring now to FIGS. 1C, 1D and 2, the treatment device 102 caninclude a non-adherent drape 148. The non-adherent drape 148 may beformed of a non-adherent material that inhibits tissue adhesion to thenon-adherent drape 148. In one embodiment, the non-adherent drape 148 isformed from a breathable polyurethane film. The non-adherent drape 148can include a plurality of openings, apertures, or fenestrations 150.The fenestrations can take a variety of shapes, such as circularopenings, rectangular openings, polygon-shaped openings, etc., but areshown in FIG. 2 as slits, or linear cuts. Depending on the particularapplication of device 102, the desired fluid flow and/or pressuredelivery, or other system parameters, the fenestrations can differentsizes.

The treatment device 102 includes the central connection member 112 towhich the plurality of encapsulated leg members 106 are coupled. Thecentral connection member 112 includes a manifold member 154 that isencapsulated by a first connection encapsulation member 186 and a secondconnection encapsulation member 192. However, a portion of the centralconnection member can fluidly couple at leg coupling areas 152 to permitfluid communication between the central connection member 112 and theplurality of encapsulated leg members 106. The first and secondconnection encapsulation members may be a defined by a single piece ofmaterial or, as illustrated, more than one sheet of material.

The central connection member 112, as discussed above, can fluidlycommunicate with manifold 122. In one aspect, fenestrations 118, similarto the fenestrations discussed above can permit fluid communication.Additionally, or alternatively, a portion or portions of the firstconnection encapsulation member can be exposed to manifold 112.

Referring again to FIGS. 1A-1D, each of the plurality of encapsulatedleg members 106 can include a leg manifold member 160, which may be asingle manifold member that runs between the leg modules 156 and/orcentral connection member 112, or individual manifold components. Theleg manifold member 160 is disposed within an interior portion 162 ofeach of the encapsulated leg members 106. Each leg manifold member 160has a first side 164 and a second, inward-facing (patient-facing) side166.

In one embodiment, one or more of the plurality of leg manifold members160 can have different material properties or structures. For example,different flow rates may be desired in different encapsulated legmembers 106. In one aspect, different manifold materials or manifoldproperties, different manifold sizes, manifold compression, the use flowrestricting material structures, and/or or valves can provide differentflow rates of fluid through the encapsulated leg members and/or centralconnection member.

In one aspect, a first leg encapsulating member 168, which can be formedwith fenestrations 114, is disposed on the first side 164 of the legmanifold member 160. A second leg encapsulating member 170, which caninclude fenestrations 116, is disposed on the second, inward-facing side166 of the leg manifold member 160. The second leg encapsulating member170 may be a portion of the non-adherent drape 148. In one embodiment,the encapsulated leg members 106 can be mated with one another, forexample, via drape 148. Alternatively, the leg members can beindependently movable with respect to one another with the exception oftheir proximal end adjacent to the central connection member 112. Forexample, the leg members need not be connected to one another. Inanother embodiment, a portion of the material connecting the legmembers, e.g., the non-adherent drape 148 between adjacent leg members106, is expandable (e.g., a stretchable, flexible, deformable, and/orelastic material) and permits movement of individual leg members 106with respect to one another.

As shown in the longitudinal cross section of FIG. 1B by arrows 172,fluid can flow from leg modules 156 towards the central connectionmember 112. As shown by arrows 174, the fluid is able to enterfenestrations 114 and 116 and flow into the leg manifold member 160 andthen flow toward the central connection member 112 as represented byarrows 172.

In plan view, the encapsulated leg members 106 may take a number ofdifferent shapes, such as elongate shapes, rectangular, elliptical, etc.In one aspect, the encapsulated leg members 106 may include leg modules156. Adjacent leg modules 156 are fluidly coupled to each other and havea manipulation zone 158 between them. In one aspect, the manipulationzone includes a weakened or perforated area to facilitate sizing of thedevice. For example, a clinician can cut through a leg module to sizethe device. By pulling on the partially cut leg module the manifold canbe torn away at the next manipulation zone. In one aspect, the recessedshape of the manipulation zone 158 can inhibit accidental removal ofadditional leg modules. Additionally, or alternatively, the outerportion of the leg modules can be fixed to the device to inhibitunwanted manifold removal.

The encapsulated leg members 106 may also have various dimensions. Ifthe longer dimension, e.g., lengthwise or longitudinal dimension, of theencapsulated leg 106 is _(L1) and the width is _(W1), then the aspectratio is given by _(L1)/_(W1). The aspect ratio may be 8.0, 7.0, 6.0,5.0, 4.0, 3.0, 2.0 or any number in between. Moreover, other aspectratios are possible. Generally, the width _(W1) of the encapsulated legmember will be greater than a width _(W2) of the central connectionmember 112, i.e., _(W2)>_(W1). For example, in one illustrativeembodiment, the encapsulated leg members 106 are approximately 270 mmlong, 60 mm wide (_(W1)), and 10 mm thick, and the central connectionmember has a width parallel to the first width (_(W1)) of about 130 mm(_(W2)). Thus, in that illustrative example, the aspect ratio of theencapsulated leg 106 is approximately (270/60) or 4.5. In this sameillustrative embodiment, the manipulation zones 158 have a width ofabout 10 mm.

Referring to FIG. 1C, a lateral cross section of a portion of theencapsulated leg member 106 is presented. As before, it can be seen thatthe first side 164 of the leg manifold member 160 is covered with thefirst leg encapsulating member 168, and that the second, inward-facingside 166 of the leg manifold member 160 is covered by the second legencapsulating member 170, which in this instance is a portion of thenon-adherent drape 148. Thus, in this illustrative embodiment, thefenestrations 116 may be some of the plurality of fenestrations 150 inthe non-adherent drape 148. In this illustrative embodiment, aperipheral edges 176 of the leg manifold member 160 are also covered bya portion of the first leg encapsulating member 168. The peripheraledges 176 include a first lateral edge 177 and a second lateral edge179. The first leg encapsulating member 168 covers the first side 164and the peripheral edges 176 and extends onto a first surface 178 of thenon-adherent drape 148 and forms extensions 180. The extensions 180 havebeen coupled to the second leg encapsulating member 170 by welds 182.The first leg encapsulating member 168 may, however, be coupled to thesecond leg encapsulating member 170 using any known technique, includingwelding (e.g., ultrasonic or RF welding), bonding, adhesives, cements,etc.

Referring again to FIG. 1D and FIG. 2, the central connection member 112includes the connection manifold member 154 that is encapsulated withinthe first connection encapsulation member 186, which has fenestrations118. The first connection encapsulation member 186 is disposed on afirst side 188 of the connection manifold member 154. The secondconnection encapsulation member 192 is disposed on a second,inward-facing side 190 of the connection manifold member 154. The secondconnection encapsulation member 192 is formed with fenestrations 120.The first connection encapsulation member 186 has a peripheral zone oredge 194 as shown in FIG. 2. In a similar fashion, the second connectionencapsulation member 192 has a peripheral zone or edge (not explicitlyshown) that lines up with the peripheral edge 194. The peripheral edge194 of the first connection encapsulation member 186 is coupled toperipheral edge of the second connection encapsulation member 192,except at the leg coupling areas 152 in order to allow fluid within theplurality of encapsulated leg members 106 to flow into the connectionmanifold member 154 as suggested by arrows 196 in FIG. 1D. Fluid mayalso enter directly into the connection manifold member 154 by flowingthrough fenestrations 120 as suggested by arrows 198. The manifold 122is disposed proximate to the first connection encapsulation member 186,and when a reduced pressure is applied to the manifold 122, the reducedpressure causes fluid to flow from the connection manifold member 154through fenestrations 118 and into the manifold 122 as suggested byarrows 200. The fluid continues to flow in the direction of thereduced-pressure interface 128 through which the fluid is removed to thereduced-pressure delivery conduit 130.

Referring to FIGS. 1A-1D and 2, in operation, the illustrativeopen-cavity, reduced-pressure system 100 may be used by first sizing thetreatment device 102 as will be explained further below in connectionwith FIG. 3A. The non-adherent drape 148 with the plurality ofencapsulated leg members 106 is disposed within the abdominal cavitythrough the body-cavity opening 126 and is distributed against theabdominal contents; this may include placing at least one encapsulatedleg member 106 in or proximate the first paracolic gutter 108, thesecond paracolic gutter 110, or behind the liver, etc. Once thetreatment device 102 has been distributed, the manifold 122 is placedadjacent a first side 184 of the first connection encapsulation member186. The sealing member 124 may then be applied over the body-cavityopening 126 to provide a pneumatic seal over the body-cavity opening126.

In addition to the sealing member 124, the body-cavity opening 126 maybe further closed or reinforced using mechanical closing means, e.g.,staples, or using a reduced-pressure closure system. The sealing member124 may be applied in a number of ways, but according to oneillustrative embodiment, the releasable backing member that is on theadhesive layer 136 of the sealing member 124 is removed and then thesealing member 124 is placed against the patient's epidermis 134 aboutthe body-cavity opening 126. The reduced-pressure interface 128, such asport 138, is then attached to the sealing member 124 such that reducedpressure can be delivered by the interface 128, through the sealingmember 124, and to the manifold 122. The reduced-pressure deliveryconduit 130 is fluidly coupled to the reduced-pressure interface 128 andto the reduced-pressure port 144 on the reduced-pressure source 132.

The reduced-pressure source 132 is activated and thereby providesreduced pressure into the reduced-pressure delivery conduit 130, whichdelivers the reduced pressure to the reduced-pressure interface 128 andinto the manifold 122. The manifold 122 distributes the reduced pressureand draws fluid through fenestrations 118 from the connection manifoldmember 154. The connection manifold member 154 draws fluid from theabdominal cavity through fenestrations 120 and pulls fluid from theplurality of encapsulated leg members 106 as suggested by arrows 196.Fluid from the abdominal cavity flows into the plurality of encapsulatedleg members 106 through fenestrations 114 on the first leg encapsulatingmember 168 and through fenestrations 116 on the second leg encapsulatingmember 170 and then flows through the leg as suggested by arrows 172towards the connection manifold member 154. The fluid then flows throughthe manifold 122, the reduced-pressure interface 128, and into thereduced-pressure delivery conduit 130.

Referring now to FIGS. 3A-3C, another illustrative embodiment of anopen-cavity, reduced-pressure treatment device 302 is presented. Theopen-cavity, reduced-pressure treatment device 302 is analogous in mostrespects to the treatment device 102 of FIGS. 1A-1D. The open-cavity,reduced-pressure treatment device 302 has a non-adherent drape 304, aplurality of encapsulated leg members 306, and a central connectionmember 308. In this particular illustrative embodiment, the non-adherentdrape 304 is formed generally with an oval or arcuate shape. Thenon-adherent drape 304 is formed with a plurality of fenestrations 305.The non-adherent drape 304 forms the second leg encapsulating member(see by analogy second leg encapsulating member 170 in FIG. 1B) and thesecond connection encapsulation member (see by analogy 192 in FIG. 1D).As such, the plurality of fenestrations 305 serves as flow channels forthe plurality of encapsulated leg members 306 and the central connectionmember 308 on the second, inward-facing side. The non-adherent drape 304could also be used on the first side of the plurality of encapsulatedleg members 306 and the central connection member 308.

Each of the encapsulated leg members 306 may be formed with a pluralityof leg modules 310 with manipulation zones 312 between the plurality ofleg modules 310. As with the manipulation zone 158 in FIGS. 1A-D, themanipulation zones 312 facilitate movement of the plurality ofencapsulated leg members 306 within the body cavity and provide aneasier location at which to cut the plurality of encapsulated legmembers 306 when the open-cavity, reduced-pressure treatment device 302is being sized for a particular application. In this regard, visualindicia 314 may be added on the non-adherent drape 304 to help thehealthcare provider know where to cut the non-adherent drape 304 fordifferent sizes of application within the cavity. The visual indicia 314may comprise cut lines, or graduations, that preferably run through themanipulation zones 312. The manipulation zones 312 provide a convenientand easy location for cutting the open-cavity, reduced-pressuretreatment device 302.

Referring to FIG. 3C, a lateral cross section of a portion of anencapsulated leg member 306 is presented. The plurality of encapsulatedleg members 306 are formed with a leg manifold member 318 having a firstside 320 and a second, inward-facing (patient-facing) side 322. A firstleg encapsulating member 324 covers the first side 320 of the legmanifold member 318 and covers a lateral zone or edge 326 of the legmanifold member 318. The second, inward-facing side 322 of the legmanifold member 318 is covered by a second leg encapsulating member 328,which in this embodiment is a portion of the non-adherent drape 304. Thefirst leg encapsulating member 324 is coupled to the second legencapsulating member 328 by any means known in the art, such as bywelding (e.g., ultrasonic or RF), bonding, adhesives, cements, etc. Inthis illustrative embodiment, the first leg encapsulating member 324 andthe second leg encapsulating member 328 are coupled by a weld 330.Referring to FIG. 3B, the weld 330 is shown along the perimeter of theplurality of leg modules 310.

Referring again to FIG. 3A, the central connection member 308 is formedanalogously to the central connection member 112 in FIG. 2. A firstconnection encapsulation member 334 and a second connectionencapsulation member of the central connection member 308 are coupledalong a peripheral edge 332 using a weld 333 or another couplingtechnique, such as those previously mentioned. The peripheral edge 332is not sealed, however, proximate each of the encapsulated leg members306 in order to provide a channel for fluid to flow from the pluralityof encapsulated leg members 306 into the central connection member 308.

According to one illustrative approach to constructing the open-cavity,reduced-pressure treatment device 302, the non-adherent drape 304, whichis already formed with the plurality of fenestrations 305 and that hasvisual indicia 314 is provided. The leg manifold member 318 is disposedadjacent the non-adherent drape 304. The central connection manifold 308is disposed adjacent to the leg manifold member 318 or may be formedintegral with leg manifold member 318. The first connectionencapsulation member 334 is placed on the central connection member 308,and the first leg encapsulating member 324 is placed over the legmanifold member 318. The first connection encapsulation member 334 andthe first leg encapsulating member 324 may be formed from an integralsheet. Next, the welds 330 and 333 are applied.

In an alternative embodiment for manufacturing an open-cavity,reduced-pressure treatment device, a first non-adherent drape 304, whichincludes fenestrations, may be provided and the leg manifold member 318and the central connection manifold 308 disposed on the firstnon-adherent drape 304. A second non-adherent drape, which hasfenestrations, is placed over the first non-adherent drape 304, the legmanifold member 318, and the central connection manifold 308. Next, aplurality of welds (e.g., thermal or RF or another coupling techniquesused) are made, such as with the welds 330. The first non-adherent drape304 and the second non-adherent drape may be cut to size before or afterassembly. By using two drapes, the first non-adherent drape 304 and thesecond non-adherent drape may provide better distribution of reducedpressure and may ease the manufacturing process.

The fenestrations may be formed before or after assembly. The perimeterof the first non-adherent drape 304 and the second non-adherent drapemay be welded. Other points may be welded between the drapes to form asingle unit. In another alternative embodiment, the drapes may initiallybe placed and welded without fenestrations, and then fenestrations addedto the drapes so that the fenestrations align. The fenestrations mightalso be formed using an electrical member that cuts and seals at thesame time to form aligned, “button hole” fenestrations through the twodrapes.

Referring now to FIG. 4, another illustrative embodiment of anopen-cavity, reduced-pressure treatment device 402 is presented. Theopen-cavity, reduced-pressure treatment device 402 is similar to thetreatment device 102 shown in FIG. 2, and to indicate analogous parts,reference numerals have been indexed by 300. The open-cavity,reduced-pressure treatment device 402 differs primarily in that a fluiddelivery subsystem 445 is included. A plurality of encapsulated legmembers 406 are shown without leg modules, and the fenestrations areshown with a circular shape. As noted before, the plurality ofencapsulated leg members 406 may be formed with or without leg modules.The fluid delivery subsystem 445 allows various fluids, such asmedicines or irrigation fluids, to be delivered into the cavity. Thedelivered fluids may then be removed by the open-cavity,reduced-pressure treatment device 402. The fluid delivery subsystem 445includes a central port 447, which may be placed on or in a centralconnection member 412, for connecting to a conduit (not shown) thatdelivers the fluid from a location external to the central port 447.Fluidly coupled to the central port 447 is a plurality of fluid-deliveryconduits 449. The plurality of fluid-delivery conduits 449 may belocated anywhere on a non-adherent drape 448, but in this illustrativeembodiment, are disposed in the plurality of encapsulated leg members406. The plurality of fluid-delivery conduits 449 are opened on theirdistal ends 451 to allow the delivery of fluid therethrough. The flow offluid through the distal ends 451 of the plurality of fluid-deliveryconduits 449 is suggested by arrows 453.

In use, the open-cavity, reduced-pressure treatment device 402 may beused in a fashion analogous to that of the treatment devices 102 and302, but at various times or even continuously, it may be desirable todeliver a fluid through the fluid delivery subsystem 445. For example,it may be desirable to flush the abdominal cavity with an irrigationfluid or to deliver periodic doses of medicine.

Another illustrative embodiment for using an open-cavity,reduced-pressure treatment device (e.g., cavity, reduced-pressuretreatment device 102, 302, 402) or system will now be presented. Thesystem is particularly suitable for temporary bridging of abdominal wallopenings where primary closure may not be readily possible and or repeatabdominal entries are necessary. The illustrative system described heremay be used with open abdominal wounds, with exposed viscera, includingbut not limited to abdominal compartment syndrome. Before applying thesystem, typically hemostasis should be achieved.

In deploying the open-cavity, reduced-pressure treatment system, thereduced-pressure treatment device preferably covers all exposed visceraand preferably separates completely the viscera from contact with theabdominal wall. For example, the lower surface of the reduced pressuretreatment device, such as drape 148, can be sized and shaped to permitcoverage. The reduced-pressure treatment device may be placed over theomentum or exposed internal organs, and carefully tucked between theabdominal wall and internal organs. In doing so, the healthcare providermay use the reduced-pressure treatment device to completely separate theabdominal wall from the internal organs.

To prepare for deployment of the system, any sharp edges or bonefragments are eliminated from wound area or covered. The abdominal woundis irrigated and the periwound area cleaned. The periwound tissue at theepidermis is typically dried before further application.

The reduced-pressure treatment device is then sized by determining theappropriate size and cutting. The reduced-pressure treatment device isinitially unfolded in a sterile field. Either side of thereduced-pressure treatment device may be placed on the omentum orviscera. The reduced-pressure treatment device is gently placed over theopen abdominal cavity. The orientation of the reduced-pressure treatmentdevice for the specific application is determined. If thereduced-pressure treatment device will be placed around tubes, drains orthe falciform ligament, the reduced-pressure device is cut only betweenthe plurality of encapsulated leg members. The reduced-pressuretreatment device is placed in the proper orientation before cutting.

The reduced-pressure treatment device is then folded to size and usedthat way or may be cut. The healthcare provider holds thereduced-pressure treatment device by the edge and slightly lifts thereduced-pressure treatment device. The reduced-pressure treatment deviceis slowly lowered into the paracolic gutter with one hand and the otherhand is used to gently and evenly work the reduced-pressure treatmentdevice down. The healthcare provider folds any excess portions of thereduced-pressure treatment device up and over onto itself. Thehealthcare provider continues to placed the reduced-pressure treatmentdevice between abdominal wall and internal organs throughout theabdominal compartment. The healthcare provider preferably provides fullcoverage of all viscera. The reduced-pressure treatment device may thenbe cut as needed for sizing outside of the wound.

To size the device, the reduced-pressure treatment device can be cutthrough center of one of the large manifold squares, or leg modules,using sterile scissors. In this illustrative embodiment, the cut is notmade through the manipulation zone, but through the leg module. Thehealthcare provider then pinches the remaining half of the foam square,or leg module, and the adjacent, inboard manipulation zone through theencapsulating member with one hand and pulls the manifold material. Themanifold material in the leg module and the manipulation zone willseparate at the next square, or leg module. This will ensure that edgesof the reduced-pressure treatment device cover the otherwise exposedmanifold edge. The manifold material, e.g., foam, preferably does notcontact organs.

The manifold that is to be placed on top of the central connectionmember is next prepared. In this embodiment, the manifold may be aperforated foam manifold that has perforations to help tear the manifoldto the desired size. The manifold preferably fits directly over thereduced-pressure treatment device while still being in contact withwound edges. The manifold should not contact intact skin. Two or moremanifolds may be used in some instances. Then, the sized manifold isgently placed into the wound cavity over the reduced-pressure treatmentdevice. The healthcare provider preferably takes care to avoid themanifold going below the level of the abdominal incision or wound.

A drape, or over-drape, is then applied. To apply the drape, a backingis removed from an adhesive layer on one side of the drape and the drapeis applied. The drape covers the manifold and a portion of intactepidermis. Preferably the drape covers at least an 8-10 centimeterborder of intact periwound tissue. Additional drape material may beadded to seal any difficult areas.

The reduced-pressure interface, or interface pad, is then added. Thehealthcare provider chooses an application site. The site is chosen tooptimize fluid flow as well as to facilitate easy tubing positioning.The healthcare provider pinches the drape and cuts a 2.5 cm hole(preferably not a slit) through the drape. The interface pad, which hasa central disc and a surrounding outer adhesive skirt, is applied. Theinterface pad is applied by removing backing layers on an inward-facingsurface of the interface pad to expose an adhesive. The interface padopening in the central disc is placed directly over the hole in thedrape. Pressure is gently applied on the central disc and the outerskirt to ensure complete adhesion of the interface pad. One or morestabilization layers may then be removed from a first side of the skirt.The system is now ready for the application of reduced pressure.

According to another illustrative embodiment, which is shown in FIG. 5,an open-cavity, reduced-pressure treatment device 502 includes a centralfluid hub 512 and a plurality of elongate members 506. The central fluidhub 512 has an upper surface 513 and a lower surface. The central fluidhub 512 includes a foam manifold 554, which defines at least a portionof the upper surface 513, and a substantially fluid impermeable wall,which defines at least a portion of the lower surface. The fluidimpermeable wall includes a plurality of apertures 518. The plurality ofelongate members 506 have a proximal end 515, distal end 517, and upper519 and lower surfaces. The elongate members 506 include a foam enclosedwithin substantially fluid impermeable walls. The proximal ends 515 ofthe plurality of elongate members 506 are in fluid communication withthe central fluid hub 512. The elongate members 506 include apertures514 extending through the fluid impermeable wall along at least aportion of the lower surface of the elongate members 506.

The plurality of elongate members 506 have a first length L₁ extendingfrom the central fluid hub 512 and a first width (W₁) generally parallelto the upper surface and perpendicular to the first length. The centralhub has a second width (W₂) between lateral edges on a portion between afirst and second elongate member. The second width is greater than thefirst width (W₂>W₁). The plurality of elongate members 506 are fluidlycoupled to the central hub 512. The open-cavity, reduced-pressuretreatment device 502 may have an aspect ratio of the plurality ofelongate members 506 in the range of 3.0 to 10.0. The open-cavity,reduced-pressure treatment device 502 may have an aspect ratio of theplurality of elongate members 506 that is greater than 3.5. Theopen-cavity, reduced-pressure treatment device 502 may also include anelastic material 585 extending between the plurality of elongate members506.

Although the present invention and its advantages have been disclosed inthe context of certain illustrative, non-limiting embodiments, it shouldbe understood that various changes, substitutions, permutations, andalterations can be made without departing from the scope of theinvention as defined by the appended claims. It will be appreciated thatany feature that is described in a connection to any one embodiment mayalso be applicable to any other embodiment.

1-13. (canceled)
 14. A method of manufacturing a reduced-pressuretreatment device for use in a body cavity of a patient, the methodcomprising: forming a plurality of encapsulated leg members, eachencapsulated leg member having a longitudinal length and an interiorportion with a leg manifold member; forming a plurality of fenestrationson the encapsulated leg members, the fenestrations positioned along thelongitudinal length of the encapsulated leg members and operable toallow fluid flow into the interior portion of the encapsulated legmembers; forming a central connection member having a connectionmanifold member; and coupling the central connection member to theplurality of encapsulated leg members, wherein each leg manifold memberis in fluid communication with the connection manifold member.
 15. Themethod of manufacturing a reduced-pressure treatment device of claim 14,further comprising forming a non-adherent drape with fenestrations,wherein forming a plurality of encapsulated leg members uses at least aportion of the non-adherent drape as an encapsulated leg member.
 16. Themethod of manufacturing a reduced-pressure treatment device of claim 15,wherein forming a non-adherent drape comprises forming an elastomericdrape, forming fenestrations through the elastomeric drape, and placingvisual indicia on the elastomeric drape that indicate various sizes forthe elastomeric drape.
 17. The method of manufacturing areduced-pressure treatment device of claim 14, wherein forming aplurality of encapsulated leg members, forming a central connectionmember having a connection manifold member, and coupling the centralconnection member to the plurality of encapsulated leg members comprise:providing a first non-adherent drape; placing a manifold unit adjacentto a surface of the first non-adherent drape, the manifold unit having aplurality of leg manifold members and a connection manifold member;placing a second non-adherent drape over the manifold unit; and couplingthe first non-adherent drape and the second non-adherent drape to formthe plurality of encapsulated leg members and the central connectionmember.
 18. The method of manufacturing a reduced-pressure treatmentdevice of claim 14, wherein forming a plurality of encapsulated legmembers, forming a central connection member having a connectionmanifold member, and coupling the central connection member to theplurality of encapsulated leg members comprise: providing a firstnon-adherent drape; placing a manifold unit adjacent to a surface of thefirst non-adherent drape, the manifold unit having a plurality of legmanifold members and a connection manifold member; placing a secondnon-adherent drape over the manifold unit; coupling the firstnon-adherent drape and the second non-adherent drape to form theplurality of encapsulated leg members and the central connection member;and cutting the first non-adherent drape and the second non-adherentdrape.
 19. The method of manufacturing a reduced-pressure treatmentdevice of claim 14, wherein forming a plurality of encapsulated legmembers, forming a central connection member having a connectionmanifold member, and coupling the central connection member to theplurality of encapsulated leg members comprise: providing a firstnon-adherent drape; placing a manifold unit adjacent to a surface of thefirst non-adherent drape, the manifold unit having a plurality of legmanifold members and a connection manifold member; placing a secondnon-adherent drape over the manifold unit; bonding the firstnon-adherent drape to the second-adherent drape to form the plurality ofencapsulated leg members and the central connection member; and cuttingthe first non-adherent drape and the second non-adherent drape.
 20. Themethod of manufacturing a reduced-pressure treatment device of claim 15,wherein forming a plurality of encapsulated leg members comprises, foreach encapsulated leg member; forming a first leg encapsulating member;forming fenestrations in the first leg encapsulating member; forming asecond leg encapsulating member; forming fenestrations in the second legencapsulating member; disposing the first leg encapsulating memberproximate a first side of a leg manifold member; wherein the legmanifold member comprises the first side, a second, inward-facing side,a first lateral edge, and a second lateral edge; disposing the secondleg encapsulating member proximate the second, inward-facing side of theleg manifold member; and coupling the first leg encapsulating member andthe second leg encapsulating member proximate the first lateral edge andthe second lateral edge of the leg manifold member.
 21. The method ofmanufacturing a reduced-pressure treatment device of claim 15, whereinforming a central connection member comprises: forming a firstconnection encapsulation member having a peripheral edge; formingfenestrations in the first connection encapsulation member; forming asecond connection encapsulation member; forming fenestrations in thesecond connection encapsulation member; and coupling at least a portionof the peripheral edge of the first connection encapsulation member tothe second connection encapsulation member.
 22. The method ofmanufacturing a reduced-pressure treatment device of claim 15, whereinforming a plurality of encapsulated leg members comprises, for eachencapsulated leg member; providing a leg manifold member, wherein theleg manifold member has a first side, a second, inward-facing side, afirst lateral edge, and a second lateral edge; forming a first legencapsulating member; forming a second leg encapsulating member; formingfenestrations in the second leg encapsulating member; disposing thefirst leg encapsulating member proximate the first side of the legmanifold member; disposing the second leg encapsulating member proximatethe second, inward-facing side of the leg manifold member; coupling thefirst leg encapsulating member and the second leg encapsulating member;and wherein forming a central connection member comprises: providing aconnection manifold member having a first side and a second,inward-facing side; forming a first connection encapsulation memberhaving a peripheral edge; forming fenestrations in the first connectionencapsulation member; forming a second connection encapsulation member;forming fenestrations in the second connection encapsulation member;disposing the first connection encapsulation member on the first side ofthe connection manifold member; disposing the second connectionencapsulation member on the second, inward facing side of the connectionmanifold member; and coupling at least a portion of the peripheral edgeof the first connection encapsulation member to the second connectionencapsulation member. 23-30. (canceled)
 31. The method of manufacturinga reduced-pressure treatment device of claim 14, wherein the legmanifold member and the connection manifold member are foam.
 32. Amethod of manufacturing a reduced-pressure treatment device for use in abody cavity of a patient, the method comprising: forming a plurality ofencapsulated leg members, each encapsulated leg member having alongitudinal length and an interior portion with a leg manifold member;providing a non-adherent drape, wherein the non-adherent drape forms atleast a portion of the encapsulated leg members; forming a plurality offenestrations on the encapsulated leg members, the fenestrationspositioned along the longitudinal length of the encapsulated leg membersand operable to allow fluid flow into the interior portion of theencapsulated leg members; forming a central connection member having aconnection manifold member; and coupling the central connection memberto the plurality of encapsulated leg members, wherein each leg manifoldmember is in fluid communication with the connection manifold member.33. The method of manufacturing a reduced-pressure treatment device ofclaim 32, wherein forming a plurality of encapsulated leg memberscomprises, for each encapsulated leg member: forming a first legencapsulating member and a second leg encapsulating member; formingfenestrations in the first leg encapsulating member and in the secondleg encapsulating member; providing a leg manifold member having a firstlateral edge and a second lateral edge; disposing the leg manifoldmember as a layer between the first leg encapsulating member and thesecond leg encapsulating member; and coupling the first legencapsulating member and the second leg encapsulating member proximatethe first lateral edge and the second lateral edge of the leg manifoldmember.
 34. The method of manufacturing a reduced-pressure treatmentdevice of claim 32, wherein forming a central connection membercomprises: forming a first connection encapsulation member having aperipheral edge; forming a second connection encapsulation member;forming fenestrations in the first connection encapsulation member andin the second connection encapsulation member; and coupling a portion ofthe peripheral edge of the first connection encapsulation member to thesecond connection encapsulation member.
 35. The method of manufacturinga reduced-pressure treatment device of claim 32, wherein the legmanifold member and the connection manifold member are foam.
 36. Amethod of manufacturing a reduced-pressure treatment device for use intreating a tissue site in a body cavity of a patient, the methodcomprising: providing a first non-adherent drape; providing a secondnon-adherent drape; positioning a manifold unit as a layer between thefirst non-adherent drape and the second non-adherent drape, the manifoldunit having a plurality of leg manifold members and a connectionmanifold member; and coupling the first non-adherent drape to the secondnon-adherent drape, thereby providing a plurality of encapsulated legmembers in fluid communication with a central connection member, eachencapsulated leg member having a longitudinal length.
 37. The method ofmanufacturing a reduced pressure treatment device of claim 36, whereincoupling the first non-adherent drape to the second non-adherent drapebonds the first and second non-adherent drape to one another around theleg manifold members and the connection manifold member.
 38. The methodof manufacturing a reduced pressure treatment device of claim 36,wherein the leg manifold members and the connection manifold member arefoam.
 39. The method of manufacturing a reduced pressure treatmentdevice of claim 36, further comprising forming a plurality offenestrations positioned along the longitudinal length of eachencapsulated leg member.
 40. The method of manufacturing a reducedpressure treatment device of claim 36, further comprising cutting thefirst non-adherent drape and the second non-adherent drape to a desiredsize.
 41. The method of manufacturing a reduced pressure treatmentdevice of claim 36, wherein a substantial portion of the longitudinallength of each of the encapsulated leg members is configured to contactthe tissue site.